Use of a Sleep System to Improve Sleep

Bed Cooling System to Effect Better Sleep

The purpose of this study is to determine the effect of a bed cooling system on subjective and objective measures of sleep in physicians who work rotating shifts. The intent of the Investigators is to perform a before-and-after trial of a bed cooling system and determine the effects of that cooling system on sleep.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Other: Bedjet; Device: FitBit

Detailed Description

All practicing providers (residents, APPs, and attendings) in the Departments/Divisions of emergency medicine, Ob/Gyn, hospital medicine and family medicine will be offered participation in the study via an email invitation.

Participants will be given a Fitbit device that measures the time of sleep and stages of sleep. Data from the Fitbit are synced to the participant's smart phone. Participants will complete the Single-Quality of Sleep (SQS) scale questionnaire on a daily basis. This questionnaire will be sent to participants on a daily basis via email. This questionnaire is a simple 0-10 rating scale of the quality of their sleep. Participants will then receive the Bedjet cooling sleep system and use it for 10 days to become acclimatized to it. Then they will use the Bedjet for 28 more days, while again completing the daily SQS. This is not a randomized trial, but rather a before-and-after trial.

Changes in mean daily sleep score, SQS from control and intervention time periods will be computed. Subjective measures of participant's satisfaction with the Bedjet system will also be obtained.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655-0002
      • UMassMemorial Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Residents, Fellows, Clinical Faculty and Advanced Practice Providers (APPs) of UMass Memorial/UMass Medical School who work rotating shifts or nightshifts in Emergency Medicine, Ob/Gyn, Hospital Medicine, or Family Medicine are eligible to participate (pregnant women are also eligible).

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bedjet arm; All participants will complete a baseline study period of 4 weeks and then will be provided the Bedjet system.	Other: Bedjet; Bedjet is a sleep cooling system. All participants will be provided a Bedjet system as part of the study.; Device: FitBit; Each participant will receive a FitBit device to track sleep quality and related information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality Scale change	change in average SQS from before and after time periods Sleep quality information will be evaluated using the Sleep Quality Scale (SQS), an [# of questions] survey that asks questions to obtain information regarding quality of sleep. The range of scores on the survey is [X] to [X], with [X] indicating poor sleep quality and (X] indicating good sleep quality. The outcome will reflect the change in score values from baseline (4 weeks) to post-use of BedJet (4 weeks)	after 4 weeks
Fitbit Sleep Score	change in average Fitbit Sleep Score from before and after implementation of the Bedjet	4 weeks before Bedjet system and the 4 weeks after

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Fitbit Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2021
• Primary Completion (ACTUAL): February 5, 2022
• Study Completion (ACTUAL): February 5, 2022

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (ACTUAL): January 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 7, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: H00023479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No